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NCT01182142 Clinical Trial

Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients

Metastatic Renal Cell Carcinoma Clinical Trial

Official title:
Phase II Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01182142
Other study ID # CRT-06.CAP
Secondary ID
Status Completed
Phase Phase 2
First received August 11, 2010
Last updated August 22, 2010
Start date September 2007
Est. completion date August 2010

Study information
Verified date August 2010
Source Kidney Cancer Research Bureau
Contact n/a
Is FDA regulated No
Health authority Russia: Ministry of Health of the Russian Federation
Study type Interventional

Clinical Trial Summary

Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. The role of capecitabine in treatment of metastatic renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of capecitabine in metastatic renal cell carcinoma patients.

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date August 2010
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- histologically confirmed non-clear cell renal cell carcinoma

- confirmed metastatic sites

- no chemotherapy in history

Exclusion Criteria:

- metastases in CNS

- previous targeted therapy

- other tumor

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Capecitabine
1,250 mg/m2 orally twice a day, days 1-14

Locations
Country Name City State
Russian Federation Natalia Petenko Moscow

Sponsors (1)
Lead Sponsor Collaborator
Kidney Cancer Research Bureau

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall response rate 12 months No
Secondary Overall survival Progression-free survival 24 months No
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